During a remote online testimony before the U.S. Senate’s Health, Education, Labor and Pensions Committee on May 12, 2020, Anthony Fauci, MD warned that moving forward too quickly with the development of a vaccine for COVID-19 may produce a vaccine that could make the disease worse.1 2 Dr. Fauci, who is the director of the National Institute of Allergy and Infectious Diseases (NIAID) and a leading member of the White House Coronavirus Task Force, said:
I must warn that there’s also the possibility of negative consequences where certain vaccines can actually enhance the negative effect of the infection. The big unknown is efficacy. Will it be present or absent, and how durable will it be.1 2
In the past two months, several pharmaceutical companies and at least one university have begun human clinical trials to test experimental vaccine candidates to prevent COVID-19 infections. Some of the manufacturers of these experimental vaccines claim they will them ready by the before the end of this year.3 4 5 6 7 Two of those companies, CureVac AG of Germany and Pfizer, Inc. of the United States (in partnership with BioNTech SE of Germany), and Oxford University of the United Kingdom have said that they expect to have COVID-19 vaccines ready by this fall.3 5 6
This ambitious schedule by CureVac, Pfizer/BioNTech and Oxford would place these vaccine development programs a full year ahead of what many scientists have estimated it would take to produce the evidence that a COVID-19 vaccine is safe and effective. Earlier this year, Dr. Fauci and Tedros Ghebreyesus, director general of the World Health Organization (WHO), estimated it would take a minimum of 12-18 months to develop a new COVID-19 vaccine. Based on that estimate, the soonest a COVID-19 vaccine could be deployed for widespread use would be sometime in early- to mid-2021.3 5
Thomas Breuer, MD, senior vice president and chief medical officer of GlaxoSmithKline Vaccines, said that even if development of a COVID-19 vaccine were to proceed at an accelerated pace, licensing approval of the vaccine would “take at least 12 to 18 months.”3
Fast Tracking New Vaccines: A Risky Business
Two incidents cited in a recent article published by the Association of American Medical Colleges (AAMC) provide examples of tragic consequences of fast tracking the use of newly created vaccines. The first example is the so-called Cutter Incident in 1955, which involved the formaldehyde inactivated Salk inactivated polio vaccine (IPV), and the second example is the RSV (respiratory syncytial virus) vaccine given to infants and toddlers in Washington, DC in 1967.8
In the Cutter Incident, about 40,000 children were given IPV developed by Jonas Salk, MD. Some 200 of those children were severely paralyzed and 10 of them died. The problem with the vaccine was linked to the failure to inactivate the live poliovirus used in the vaccine. According to an article by Janine Roberts in The Ecologist, “The general consensus was that these cases had been caused by viruses in the vaccine that had survived the formaldehyde” used to supposedly kill them.8 9
The children injected with the formalin inactivated RSV vaccine in 1966-67 experienced an enhanced form of RSV disease (which causes pneumonia in infants) when they were exposed to and became infected with wild-type respiratory syncytial virus in the community.10
The risk of a COVID-19 vaccine enhancing the complications of an infection it is designed to prevent, which occurred with the experimental RSV given to infants and children in the 1960’s, is referred to as “immune enhancement.” Some of the COVID-19 vaccines currently undergoing human clinical trials have skipped animal trials, which is a key step in the normal process of developing and licensing new vaccines.12
1 Camero K. Fauci warns there’s a risk rushing a coronavirus vaccine. Miami Herald May 12, 2020.
2 Fox News. Dr. Fauci testifies before Senate on coronavirus response. YouTube May 12, 2020.
3 Cáceres M. A Vaccine for Coronavirus by Autumn? The Vaccine Reaction Apr. 2, 2020.
4 TVR Staff. Bill Gates Says Health Care Workers Will Be First to Get Coronavirus Vaccine. The Vaccine Reaction Mar. 20, 2020.
5 TVR Staff. Oxford Begins COVID-19 Vaccine Trials to Meet September Deadline. The Vaccine Reaction Apr. 27, 2020.
6 TVR Staff. Pfizer/BioNTech Target Fall 2020 for COVID-19 Vaccine Availability. The Vaccine Reaction May 3, 2020.
7 U.S. National Library of Medicine. Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults (CTCOVID-19). ClinicalTrials.gov Mar. 18, 2020.
8 Boyle P. Here’s why we can’t rush a COVID-19 vaccine. Association of American Medical Colleges Mar. 31, 2020.
9 Cáceres M. Embalming Fluid in Vaccines? The Vaccine Reaction Apr. 30, 2018.
12 Rushing vaccine for coronavirus may make patients sicker. Irish Examiner Mar. 12, 2020.